NICE recommends Sanofi's oral MS drug

Aubagio backed for NHS use in England and Wales

NHS patients in England and Wales will now have access to another oral multiple sclerosis (MS) drug after Sanofi's Aubagio was backed by healthcare authorities.

The National Institute for Health and Care Excellence (NICE) decided that Aubagio (teriflunomide) was a cost-effective use of NHS resources to treat certain adults with the relapsing-remitting form of MS, which is thought to affect eight out of 10 people with the autoimmune condition.

The recommendation follows previous negative NICE guidance, with the watchdog demanding more information about Aubagio, which was acquired by Sanofi as part of its purchase of Genzyme.

Sanofi addressed these issues in December last year, while also agreeing to provide the drug at a discount through a patient access scheme, leading to a reversal of NICE's draft guidance.

NICE has now finalised the positive recommendation, which includes the patient access scheme as well as a recommendation that Aubagio only be used to treat adult patients who do not have highly active or rapidly evolving severe RRMS.

This is an expanded recommendation compared to Novartis' Gilenya (fingolimod), the first oral MS drug to be recommended by NICE.

Novartis' rival drug was backed in 2012 if supplied through a patient access scheme and only for patients who have an unchanged or increased relapse rate or ongoing severe relapses compared to the previous year, despite them taking other drugs such as beta interferons.

Nick Rijke, director for policy and research at the MS Society, commented on what the Aubagio approval means for MS patients in the UK.

"We've been waiting a long time for a tablet to be available for early stage MS, so this is excellent news,” he said. “As well as making another valuable treatment available for people with MS, many people will be delighted to have the option of a tablet rather than regular injections, which can be difficult to manage."

Aubagio and Gilenya are two of three new oral MS drugs to hit the market in the past couple of years, marking a great advance in the ease of dosing for MS patients.

The third drug – Biogen Idec's Tecfidera (dimethyl fumarate) – has been recommended by the European Medicines Agency (EMA) for use in the EU but has yet to be granted final approval due to patent and regulatory data protection issues.

These were resolved in November last year, which should pave the way for final marketing approval from the European Commission and the opportunity to be assessed by market access bodies, such as NICE.